FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 1861200
·
Received October 4, 2010
Report
- Report Number
- 1720753-2010-03351
- Event Type
- Malfunction
- Date Received
- October 4, 2010
- Date of Event
- September 20, 2010
- Report Date
- October 4, 2010
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE BATTERIES. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM HAD A KVP ERROR ON THE C-ARM DISPLAY. THEY WERE ABLE TO CLEAR THE ERROR AND COULD CONTINUE TO IMAGE. THE ERROR HAPPENED SEVERAL TIMES. THE PROBLEM SEEMED TO HAPPEN WITH THE FOOT SWITCH. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |